Plasma Biomarkers P-DAC, V1

Terminated

• Conditions: Pancreatic Ductal Adenocarcinoma

• Registration Number: NCT02050997
• Lead Sponsor: Cancer Trials Ireland

Brief Summary

This is an exploratory, translational, non-interventional and multi-centre clinical study. The aim of the study is to identify predictive plasma biomarkers of response to chemotherapy in PDAC.

Detailed Description

This study will involve two cohort groups, all patients involved will have PDAC.

Cohort A: Target is 80 resectable PDAC patients who will receive standard treatment of chemotherapy +/- radiotherapy

Cohort B:

* Cohort B1 = Target is 80 unresectable locally advanced PDAC patients who will receive standard treatment of chemotherapy +/- radiotherapy.

* Cohort B2 = Target is metastatic PDAC patients who will receive standard treatment of chemotherapy +/- radiotherapy.

Control patients: Target is 50, with acute pancreatitis admitted to hospital for observation/treatment.

Blood samples will be taken at the following time points:

* prior to resection, whenever feasible for cohort A

* prior to CT, for both cohort A and B

* during CT, for both cohort A and B

* follow-up, approximately every 3 to 6 months for two years for cohort A

Study Timeline

• Study First Submitted: 2014-01-24
• Study First Submitted QC: 2014-01-29
• Study First Posted: 2014-01-31
• Study Start: 2014-05-26
• Primary Completion: 2021-12
• Study Completion: 2021-12
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

• Age ≥ 18 years of age
• Ability to give written informed consent
• Histologically or cytologically-confirmed PDAC
• Patients who will receive standard treatment of CT +/- radiotherapy and present with:

Cohort A: resectable cancer OR Cohort B.1: unresectable locally advanced cancer OR Cohort B.2: metastatic cancer

• Eastern Cooperative Oncology Group (ECOG) Performance status 0 - 2

Exclusion Criteria

• Presence of medical or psychiatric conditions, which, in the opinion of the investigator, would potentially pose a risk to the patient in participating in this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to disease recurrence	Blood samples analysed up to 2 year follow up, estimated 4 years in total	Identify plasma biomarkers that are predictive for response to treatment as defined by time to recurrence

Secondary Outcome Measures

Name	Time	Method
Rate of progression free survival	Blood samples analysed up to 2 year follow up, estimated 4 years in total	To discover plasma biomarkers that are predictive for response to treatment as defined by progression free survival
Accuracy, sensitivity, specificity and concordance index	For the duration of study, expected 4 years	Aim to validate a panel of predictive plasma biomarkers proving its accuracy, sensitivity, specificity and to investigate their expression at tissue level gaining a further understanding of cancer and/or host related proteins in disease response and progression

Trial Locations

Locations (9)

Our Lady of Lourdes Hospital Drogheda; 🇮🇪 Drogheda, Louth, Ireland

Beacon Hospital; 🇮🇪 Dublin, Dublin 18, Ireland

Bon Secours; 🇮🇪 Cork, Ireland

Midwestern Regional Hospital; 🇮🇪 Limerick, Ireland

St Vincent's Hospital; 🇮🇪 Dublin, Ireland

Galway University Hospital; 🇮🇪 Galway, Ireland

Adelaide Meath National Childrens Hospital; 🇮🇪 Tallaght, Ireland

Waterford Regional Hospital; 🇮🇪 Waterford, Ireland

Beaumont Hospital; 🇮🇪 Dublin, Ireland